# K061464: Vitros Chemistry Products Tibc Kit, Model 886 7541; Calibrator Kit 4, Model 120 4668

- Pathway: 510(k) (Special)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Jun 15, 2006 after 21 days
- Product code: JMO (Ferrozine (Colorimetric) Iron Binding Capacity)
- Device class: 1
- Regulation: 21 CFR 862.1415
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K931493 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931493: Kodak Ektachem Total Iron-Binding Capacity Kit, Eastman Kodak Company (1993) Summary page 1.

## Indications for use
For in vitro diagnostic use only. VITROS Chemistry Products TIBC Kit with VITROS Chemistry Products Fe Slides quantitatively measures total iron-binding capacity (TIBC) in serum. The iron binding capacity is useful in the differential diagnosis of anemia, iron deficiency anemia, thalassemia, sideroblastic anemia, and iron poisoning. VITROS Chemistry Products Calibrator Kit 4 is used to calibrate VITROS Chemistry Systems for the quantitative measurement of ALB, BuBc, Fe, TBIL, TIBC, and TP.

Source page: https://510kreport.com/device/K061464
Methodology: https://510kreport.com/methodology